- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03538288
Feasibility Trial of rTMS for Cannabis Use Disorder
July 31, 2018 updated by: Medical University of South Carolina
A Pilot Trial Determining the Feasibility of Delivering Twenty Treatments of Repetitive Transcranial Magnetic Stimulation (rTMS) to Treatment Seeking Cannabis Use Disordered Participants
This small pilot trial will recruit 10 cannabis use disordered participants and apply 20 sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling treatment paradigm.
The investigators are primarily seeking to determine if the proposed paradigm is feasible and well tolerated.
Study Overview
Detailed Description
The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS is feasible and well tolerated by a group of treatment seeking CUD patients (Aim1).
The investigators are also hoping to preliminarily determine if a course of rTMS reduces cannabis cue-induced craving (Aim2).
Additionally the investigators want to preliminarily explore the mechanistic underpinnings of any observed effect by collecting functional magnetic resonance imaging (fMRI) data during cannabis cue-administration before and after the treatment course (Aim 3).
These aims will be addressed through an open label study in which 10 treatment seeking cannabis use disordered participants will be given 20 sessions of Active excitatory rTMS applied to the DLPFC.
TMS will be delivered in an accelerated fashion over two weeks (2 sessions each day, five days each week).
TMS will be applied in conjunction with a validated two-session Motivational Enhancement Therapy (MET) behavioral intervention.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must be between the ages of 18 and 60.
- Participants must meet DSM-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 / last 28 days.
- Participants must express a desire to quit cannabis.
- Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).
Exclusion Criteria:
- Participants must not be pregnant or breastfeeding.
- Participants must not test positive for any substance other than cannabis on UDS during their enrollment visit.
- Participants must not meet moderate or severe use disorder of any other substance with the exception of Tobacco Use Disorder.
- Participants must not be on any medications that have central nervous system effects.
- Participants must not have a history of/or current psychotic disorder or bipolar disorder.
- Participants must not have any other Axis I condition requiring current treatment and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms.
- Participants must not have a history of dementia or other cognitive impairment.
- Participants must not have active suicidal ideation or a suicide attempt within the past 90 days.
- Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion).
- Participants must not have any unstable general medical conditions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Twenty sessions of rTMS
Twenty sessions of rTMS will be applied to treatment seeking participants.
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rTMS will be applied at 10 Hz to the DLPFC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine if a course of rTMS is feasible to deliver and well tolerated by a group of cannabis use disordered participants.
Time Frame: 7 weeks
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The investigators will test the hypothesis that at least 50% of enrolled participants will complete the trial.
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7 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregory Sahlem, Instructor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
September 7, 2016
First Submitted That Met QC Criteria
May 15, 2018
First Posted (Actual)
May 29, 2018
Study Record Updates
Last Update Posted (Actual)
August 2, 2018
Last Update Submitted That Met QC Criteria
July 31, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00054706
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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